Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01074268
First received: February 22, 2010
Last updated: January 12, 2016
Last verified: January 2016
Results First Received: October 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
Interventions: Drug: insulin degludec
Drug: insulin detemir
Drug: insulin aspart

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 55 sites in 7 countries: Brazil (2), Finland (8), India (10), Italy (6), Japan (15), Macedonia (1) and United Kingdom (13). For the extension trial, one trial site in Italy did not enroll any subject since approval was not obtained before the start of the trial from the IEC.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects who completed the 26-week main trial (NN1250-3585, NCT01074268) and were found to be eligible for the extension trial were offered to participate in the 26-week extension trial (NN1250-3725). The total duration of treatment was 52 weeks (26 weeks + 26 weeks), separated by 1 week of follow-up from the main trial.

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
IDet OD Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Participant Flow for 2 periods

Period 1:   Main: Week 0 to 26 (NN1250-3585)
    IDeg OD     IDet OD  
STARTED     303     153  
Full Analysis Set     302 [1]   153  
Exposed     301 [2]   152 [3]
COMPLETED     283     138  
NOT COMPLETED     20     15  
Adverse Event                 3                 1  
Lack of Efficacy                 0                 2  
Protocol Violation                 3                 4  
Withdrawal criteria                 6                 3  
Unclassified                 8                 5  
[1] One subject was withdrawn because the subject was randomised in error (screening failure)
[2] Two subjects withdrew prior to exposure to trial drugs
[3] One subject withdrew prior to exposure to trial drugs

Period 2:   Extension: Week 27 to 52 (NN1250-3725)
    IDeg OD     IDet OD  
STARTED     248 [1]   122 [2]
COMPLETED     242     115  
NOT COMPLETED     6     7  
Adverse Event                 1                 1  
Protocol Violation                 0                 2  
Withdrawal criteria                 2                 2  
Unclassified                 3                 2  
[1] Thirty five subjects from main trial did not continue into the extension
[2] Sixteen subjects from main trial did not continue into the extension



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
IDet OD Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
Total Total of all reporting groups

Baseline Measures
    IDeg OD     IDet OD     Total  
Number of Participants  
[units: participants]
  302     153     455  
Age  
[units: years]
Mean (Standard Deviation)
  41.1  (14.9)     41.7  (14.4)     41.3  (14.7)  
Gender  
[units: participants]
     
Female     152     67     219  
Male     150     86     236  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.0  (1.0)     8.0  (0.9)     8.0  (0.9)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.9  (4.0)     9.5  (4.0)     9.8  (4.0)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment   [ Time Frame: Week 0, Week 26 ]

2.  Primary:   Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]

3.  Secondary:   Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 52 ]

4.  Secondary:   Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26   [ Time Frame: Week 26 ]

5.  Secondary:   Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52   [ Time Frame: Week 52 ]

6.  Secondary:   Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment   [ Time Frame: Week 0, Week 26 ]

7.  Secondary:   Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 52 ]

8.  Secondary:   Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

9.  Secondary:   Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

10.  Secondary:   Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]

11.  Secondary:   Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01074268     History of Changes
Obsolete Identifiers: NCT01190956
Other Study ID Numbers: NN1250-3585
2009-011672-29 ( EudraCT Number )
U1111-1111-7249 ( Other Identifier: WHO )
JapicCTI-101067 ( Registry Identifier: JAPIC )
2009-015721-36 ( EudraCT Number )
U1111-1114-9479 ( Other Identifier: WHO )
JapicCTI-22-0677 ( Registry Identifier: JAPIC )
Study First Received: February 22, 2010
Results First Received: October 15, 2015
Last Updated: January 12, 2016
Health Authority: Brazil: National Health Surveillance Agency
Finland: Finnish Medicines Agency
India: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Macedonia, The Former Yugoslav Republic of: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency